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Seres Argues Different Diagnostic Needed In Recurrent C. Difficile Trials

 
• By Emily Hayes

As it talks study design with FDA, Seres says new analysis of Phase II trial of microbiome candidate SER-109 suggests that a C. difficile cytotoxin test would be more accurate and that a higher dose may be more effective.

3d render illustration of human digestive system - front view

Seres Therapeutics Inc. is talking to FDA about using a different dose and a diagnostic that departs from the current standard of care in a new trial of its microbiome candidate SER-109 for recurrent Clostridium difficile infection, after conducting a detailed analysis of a failed mid-stage trial.

The company reported in July that the candidate, which is derived from donors' fecal matter using the company's proprietary microbiome platform technology, failed in a randomized, placebo-controlled Phase II study

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